A Study Comparing Outcomes of Kidney Transplants in Patients on Steroids Versus Those Who Discontinue Steroids
Recruitment status was Active, not recruiting
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Purpose
The purpose of this study is to compare the risks and benefits of steroid elimination versus steroid therapy in renal transplant patients particularly looking at the effects on bone mass, lipids, hypertension, and new onset diabetes.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Diseases |
Drug: prednisone |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | A Single Center, Open Label, Comparative, Controlled Trial to Assess the Risks and Benefits of Steroid Elimination vs. Steroid Therapy After Renal Transplantation |
- Acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patient and graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Incidence of infection [ Time Frame: one year ] [ Designated as safety issue: No ]
- Quality of life (health survey) [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of post-transplant diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]
- Incidence of osteopenia/osteoporosis at baseline and one year [ Time Frame: one year ] [ Designated as safety issue: No ]
- Renal function [ Time Frame: one year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2008 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
subjects who remain on steroids after discharge
|
|
|
2
Subjects will be off steroids at the time of discharge
|
Drug: prednisone
group 2 will remain on 5 mg of prednisone for at least 90 days post transplant.
|
Detailed Description:
The use of steroids after renal transplantation has been invaluable, resulting in higher rates of long term survival of the transplanted kidney. However, post-operative steroids are also associated with frequent post-operative and long term complications. There have been steroid elimination studies analyzing acute rejection rates, graft and patient survival. These studies show that many patients can safely have steroids withdrawn with equivalent results whan compared to those who remain on steroids.
With this study we will be using a rapid steroid elimination protocol for 40 patients and compare 20 patients who remain on steroids. We hope to show a decreased rate of complications such as osteopenia/osteoporosis, new onset diabetes, and a decrease in cardiovascular risk factors such as hyperlipidemia and hypertension.
Solumedrol will be given to all patients at the time of transplant followed by a prednisone taper. Those remaining on steroids will be discharged on prednisone 5 mg daily. Those in whom steroids are eliminated will be off prednisone by discharge.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
de novo renal transplant recipients
Inclusion Criteria:
- Patients undergoing a single renal transplant from deceased or living donor
- Adults 18 years and older
- First or second renal transplant
- Capable of understanding the purposes of the study, has given written informed consent, and agrees to comply with the study requirements
- Women of child bearing age should have a negative serum pregnancy test
Exclusion Criteria:
- Greater than 2 renal transplants
- Age < 18 years
- Patients receiving immunosuppressive therapy within the preceding 28 days for first transplant and 3 months for the second transplant
- Cold ischemia time > 30 hours
- History of malignancy in the last 5 years except successfully treated localized non-melanoma skin cancer
- HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) positive serology
- Loss of previous transplant in < 1 year
- History of non-compliance
- Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may impair communication with the investigator or compliance with study procedures
- Multiple organ transplant
- History of chronic steroid use except for inhaled steroids for asthma
- Pregnant or lactating females
- Women of childbearing potential not willing to use a reliable form of contraception.
- Patients with severe medical condition(s) that, in the view of the investigator, prohibits participation in the study
- Known sensitivity to study drugs or class of study drugs
- Use of any investigational agent in the last 30 days
Contacts and Locations| United States, Florida | |
| Florida Hospital Transplant Center | |
| Orlando, Florida, United States, 32804 | |
| Principal Investigator: | Michael Angelis, MD | Florida Hospital Transplant Center |
More Information
No publications provided
| Responsible Party: | Michael Angelis, MD, Florida Hospital Transplant Center |
| ClinicalTrials.gov Identifier: | NCT00273559 History of Changes |
| Other Study ID Numbers: | TL092005-1 |
| Study First Received: | January 5, 2006 |
| Last Updated: | May 8, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Florida Hospital Transplant Center:
|
Renal Transplantation |
Additional relevant MeSH terms:
|
Kidney Diseases Urologic Diseases Prednisone Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013